Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2026-01-04 @ 9:37 AM
Study NCT ID:
NCT03472261
Status:
COMPLETED
Last Update Posted:
2020-04-16
First Post:
2018-03-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Integrated Management of Pronation Deformity in Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-15', 'studyFirstSubmitDate': '2018-03-14', 'studyFirstSubmitQcDate': '2018-03-20', 'lastUpdatePostDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assisting Hand Assessment (AHA)', 'timeFrame': 'Week 12', 'description': 'Bilateral hand use'}], 'primaryOutcomes': [{'measure': 'Mean change from baseline Modified Ashworth Scale (MAS)', 'timeFrame': 'Week 12', 'description': 'Tone measurement'}], 'secondaryOutcomes': [{'measure': 'Mean change from baseline passive range of supination', 'timeFrame': 'Week 12', 'description': 'Range of motion measurement'}, {'measure': 'Mean change from baseline angle of catch (XV3) Tardieu scale', 'timeFrame': 'Week 12', 'description': 'Spasticity measurement'}, {'measure': 'Mean change from baseline active range of supination', 'timeFrame': 'Week 12', 'description': 'Active range of motion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cerebral palsy', 'botulinum toxin-A', 'pronator deformity'], 'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'Pronation deformity is a very common problem in children with cerebral palsy. This deformity is usually has neural and non-neural aspects. In this clinical trial the aim is to show the importance of combine treatment approach with pharmacological and non-pharmacological modalities. .', 'detailedDescription': 'Spasticity is not only the most common motor disorder but also the main cause of slowly developing contractures in children with cerebral palsy. Pronation deformity which is a very common problem in children with cerebral palsy is primarily due to spasticity of the pronator muscles. Reduced strength and loss of control of the supinator muscles and soft tissue and joint contractures usually coexist with spasticity of pronator muscles. There is very limited information about how to treat this deformity in the current literature.\n\nIn this prospective, randomized, controlled clinical trial the aim is to show the effectiveness of twister, and home exercise program in an integrated approach with BoNT-A injections on spasticity, and passive range of motion (pROM) of children with CP having pronation deformity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of cerebral palsy\n* MAS score of pronator muscles at least 2\n* Gross Motor Functional Classification Scale level of I-IV\n* Scheduled to receive botulinum toxin injections to pronator teres and/or -pronator quadratus muscles besides other spastic upper extremity muscles\n\nExclusion Criteria:\n\n* Severe cognitive or behavioural problems\n* Less than 40 degrees of available passive range of motion in pronation\n* Severe dystonia in the affected upper limb\n* Received orthopedic surgery to affected upper limb'}, 'identificationModule': {'nctId': 'NCT03472261', 'briefTitle': 'Integrated Management of Pronation Deformity in Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'A Randomized Controlled Trial on Integrated Management of Pronation Deformity of Children With Cerebral Palsy Treated by Botulinum Toxin-A', 'orgStudyIdInfo': {'id': 'KU GOKAEK 2018/8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group', 'description': 'Patients treated by Botulinum toxin A and twister and specific home exercise program', 'interventionNames': ['Drug: Botulinum toxin type A', 'Other: Upper extremity orthoses', 'Other: Home exercise program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Therapy Group', 'description': 'Patients treated by Botulinum toxin A and specific home exercise program', 'interventionNames': ['Drug: Botulinum toxin type A', 'Other: Home exercise program']}], 'interventions': [{'name': 'Botulinum toxin type A', 'type': 'DRUG', 'description': 'Dysport', 'armGroupLabels': ['Conventional Therapy Group', 'Experimental Group']}, {'name': 'Upper extremity orthoses', 'type': 'OTHER', 'description': 'Twister', 'armGroupLabels': ['Experimental Group']}, {'name': 'Home exercise program', 'type': 'OTHER', 'description': 'Specific exercises for pronation deformity', 'armGroupLabels': ['Conventional Therapy Group', 'Experimental Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41050', 'city': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}], 'overallOfficials': [{'name': 'Melike Akarsu, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kocaeli University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Nigar Dursun', 'investigatorAffiliation': 'Kocaeli University'}}}}